Professional Regulatory Affairs - Regulatory Operations

Description Overview

We are excited to recruit an Associate Professional Regulatory Affairs within Regulatory Operations, you will play an important role in supporting Perrigo's regulatory systems, data and digital capabilities, helping to ensure regulatory information is accurate, compliant, accessible and effectively managed throughout the product lifecycle. 

You will be responsible for maintaining and improving regulatory data, supporting system usage, identification of future requirements, develop processes and workflows, and contributing to the effective operation of regulatory platforms and tools. Working closely with Regulatory Affairs colleagues across the Operations team as well as with the Regulatory Affairs Lifecycle Management, Category, Cluster and other cross-functional teams, you will help ensure regulatory information data obligations are met and maintained to a high standard and supports compliant regulatory submissions, reporting and business activities. 

This role will support the ongoing development and optimisation of regulatory operations systems, data governance processes and performance reporting. You will contribute to improving data quality, process consistency and system adoption, while helping identify opportunities to enhance efficiency, visibility and operational effectiveness across Regulatory Affairs. 

Working collaboratively with stakeholders, you will support data investigations, process improvements, system enhancements and reporting activities. You will help identify and resolve data quality issues, support implementation of new ways of working and contribute to the successful delivery of regulatory operations initiatives. 

As an experienced regulatory operations professional, you will apply your technical expertise and analytical skills to support effective system and data management practices. You will contribute to the continuous improvement of regulatory processes, systems and metrics, helping to promote operational excellence, right-first-time quality and a data-driven approach to decision making. 

This role offers the opportunity to make a meaningful contribution within the Regulatory Affairs organisation by supporting regulatory systems and data capabilities that enable compliant regulatory delivery, improve operational efficiency and help Perrigo continue its digital transformation journey. 

Scope of the Role

• Manages regulatory systems and data activities across multiple products, markets and regulatory workstreams, supporting the accurate, compliant and efficient execution of regulatory operations. 
• Provides expertise in regulatory data management, systems, reporting and process improvement, helping to optimise business processes and enhance operational performance. 
• Contributes to governance, continuous improvement and operational excellence initiatives, driving data quality, process consistency and adoption of scalable ways of working across Regulatory Affairs. 
• Independently manages regulatory systems and data activities across products, markets and workstreams to support compliant, efficient regulatory operations. 
• Works independently within delegated authority, resolving operational issues and improving systems, data quality, workflows and processes. 
• Leads or contributes to systems, data governance, process improvement and digitalisation initiatives across products, functions and regulatory processes. 
• Partners across Regulatory Affairs, Quality, Supply Chain, Safety, IT and other stakeholders to support accurate data, effective system use and scalable ways of working. 
• May support other regulatory operations activities as business needs require. 

Systems, Data & Digital Capability 

• Manage regulatory systems and data across products, markets and workstreams, ensuring information is accurate, complete, compliant and maintained to requirements. 
• Support administration, maintenance and optimisation of regulatory systems, workflows and data structures to improve usability, efficiency and data quality. 
• Investigate and resolve regulatory data issues, including discrepancies, process gaps and system-related challenges. 
• Support system enhancements, implementations, upgrades and change initiatives through requirements gathering, testing and business adoption. 
• Contribute to data governance, ensuring regulatory information is managed, traceable and aligned across systems, products and processes. 

Process Improvement, Reporting & Operational Excellence 

• Develop, maintain and analyse regulatory metrics, reports and dashboards covering performance, workload, compliance, data quality and outcomes. 
• Use system and operational data to identify trends, risks and improvement opportunities, and provide recommendations. 
• Support SOPs, work instructions, business processes and data standards to drive consistency and scalability. 
• Contribute to digitalisation and process improvements that enhance efficiency, reporting, system adoption and user experience. 
• Represent regulatory systems and data requirements in cross-functional projects and business solutions. 

Governance, Compliance & Stakeholder Partnership 

• Support inspection-ready regulatory systems and data in line with regulatory requirements, procedures and governance standards. 
• Partner with Regulatory Affairs, Quality, Supply Chain, Safety and IT to support system use, process compliance and operational delivery. 
• Assess and escalate data, system or process risks, supporting timely resolution and corrective actions. 
• Provide user guidance on regulatory systems, data processes and reporting requirements to promote consistent, compliant ways of working. 
• Maintain awareness of regulatory data standards, digital capabilities and industry trends to strengthen operations and data integrity. 

Experience Required

• Typically 3–5 years' experience in Regulatory Affairs for healthcare products, Regulatory Operations, regulatory systems, data management or related operational roles; relevant scientific, technical or regulatory degree preferred. 
• Experience working with regulatory systems, regulatory data, reporting, workflows or operational processes supporting regulatory activities. 
• Demonstrated ability to independently manage activities, resolve issues and coordinate effectively with cross-functional stakeholders. 
• Experience supporting process improvement, system enhancements, reporting or data quality initiatives. 
• Strong analytical, organisational and communication skills, with the ability to work effectively in a matrixed environment.